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News From the Food and Drug Administration
August 1, 2001

New Device for Procedures on Diseased Bypass Grafts

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JAMA. 2001;286(5):527. doi:10.1001/jama.286.5.527-JFD10007-2-1

The FDA has approved the PercuSurge GuardWire Plus Temporary Occlusion and Aspiration System (PercuSurge Inc, Sunnyvale, Calif), for procedures on diseased coronary artery bypass grafts. The device is indicated for use in coronary saphenous vein bypass grafts to contain and aspirate embolic material while performing percutaneous transluminal coronary angioplasty or stenting procedures.

The device consists of a catheter with a distal elastomeric occlusion balloon, an introducer sheath, an adapter for controlling inflation and deflation of the balloon, and an inflator that delivers a controlled volume of diluted contrast media to inflate the balloon. The inflator contains a syringe for catheter preparation and balloon deflation. The syringe also serves as a reservoir for contrast solution.